Introduction to COVID-19

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2).

This novel coronavirus was first identified in December 2019. In March 2020, the World Health Organization (WHO) declared the COVID-19 outbreak a pandemic.

The time between exposure to the virus and symptom onset is typically around five days but may range from two to fourteen days.

Common symptoms are similar to seasonal flu. While the majority of cases result in mild symptoms, some progress to viral pneumonia and multi-organ failure.

There is no cure available. Even with a vaccine, testing remains crucial in the fight against COVID-19.

COVID-19 testing options

Two kinds of tests are available for COVID-19: serological test and molecular test.

The serological test

The serological test detects antibodies against the virus in serum samples. The presence of antibodies indicates exposure to the virus and the body’s response to infections. Although antibodies that result from SARS-CoV-2 infection may provide some immunity, the level, and duration of immunity are not yet known.

The molecular test

The molecular test detects genetic material of the virus in respiratory specimens (such as nasopharyngeal or oropharyngeal swabs). Quantitative reverse transcription PCR (RT-qPCR) is the gold standard to diagnose COVID-19.

Serology Testing

SBC COVID-19 IgG ELISA Kit

Qualitative assessment of IgG

The SBC COVID-19 IgG ELISA Kit is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for qualitative detection of IgG antibodies to SARS-CoV-2 in human serum.

* High sensitivity and specificity

97.1% positive percent agreement (95% CI, 85.5%-99.5%)
Estimated by testing 35 serum samples from patients that were confirmed positive for SARS-CoV-2 by US FDA authorized PCR 15-40 days prior to serum collection.

100% negative percent agreement (95% CI, 95.8%-100%)
Estimated by testing 87 serum samples collected in the US prior to December 2019.

* Full-length spike protein coated microplates (S1 and S2).

* Microplate in strip format (adjustable to sample size)

* Compatible with various open platform ELISA analyzers

* For Research use only

Molecular Testing

Spin column
One-step (under development)
Automated magnetic bead-based

Internal control included
High sensitivity & specificity

Lab-based testing (Mini qPCR)

SBC COVID-19
NAT SOLUTION

Ready to use
reagents for qPCR

Design

Gene targets: ORF1ab and N
RNase P as internal control to prevent false negatives

Performance characteristics

100% match to sequences of SARS-CoV-2 isolates.
No cross reactivity with common respiratory flora and other viral pathogens.
The LoD was determined to be 10 copies/reaction (0.4 copies/µl) for both ORF1ab and N gene.